BIO From The Editor and Guest Columns

  1. GlycoNex On Challenges In Biosimilar Development, Manufacturing 1/29/2025

    In this written Q&A, GlycoNex president and CEO, Dr. Mei-Chun Yang, shares insight into the company's development of its denosumab biosimilar, SPD8. She covers the company’s approach to analytics, cell line development, scaling, and more.

  2. Top 10 Data Auditor Statistical Software Requests 1/27/2025

    Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.

  3. Computer Systems Validation Pitfalls, Part 4: Inattention To Details 1/24/2025

    The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

  4. How 'Explainable ML' Can Improve Process Performance 1/23/2025

    In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.

  5. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

    The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

  6. Easing Autologous Cell Collection, Automating Manufacturing 1/22/2025

    To circumvent the challenges of leukapheresis, CellProthera developed a novel method for collecting therapeutic stem cells from whole blood. CSO Ibon Garitaonandia, Ph.D., discusses the company's mission to streamline manufacturing.

  7. Using Simple Spreadsheet DoE To Optimize The Protein Pipeline 1/21/2025

    Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

  8. Suffering High Protein Sieving Losses? It Might Be The Buffer 1/17/2025

    New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.

  9. Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation 1/16/2025

    API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.

  10. Building Frameworks To Support Complex Therapy Manufacturing 1/16/2025

    To make its clinical product, CLBR001+SWI019, the Calibr-Skaggs Institute for Innovative Medicines relies on a complex network of contractors from around the globe.